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FDA 510(k)

BETA-TCP GRANULES

K-Number: K120354 · 2013-03-21

ApplicantSkeletal Kinetics, LLC
Decision Date2013-03-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BETA-TCP GRANULES is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Kinetics, LLC. It received FDA 510(k) clearance on 2013-03-21 under 510(k) number K120354. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA-TCP GRANULES?

BETA-TCP GRANULES is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Skeletal Kinetics, LLC. The 510(k) number is K120354.

When did BETA-TCP GRANULES receive FDA 510(k) clearance?

BETA-TCP GRANULES received FDA 510(k) clearance on 2013-03-21, under 510(k) number K120354.

Who is the listed applicant for BETA-TCP GRANULES?

The FDA 510(k) record lists Skeletal Kinetics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BETA-TCP GRANULES?

The FDA product code for BETA-TCP GRANULES is MQV.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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